HPTN SDMC: HPTN 096 Getting to Zero among Highest HIV Incidence (HHI) Men who have Sex with Men (MSM) in the American South: Testing an Integrated Strategy

Abstract (30 lines) The Southern United States continues to experience the highest HIV incidence in the country, with men who have sex with men (MSM) disproportionately affected. HPTN 096 is a multi-component, community-based implementation-efficacy trial designed to reduce HIV incidence among the highest HIV incidence (HHI) MSM in three urban American South communities. The primary study outcomes are increasing the number of HHI MSM accessing prevention and treatment services, increasing uptake and use of pre-exposure prophylaxis (PrEP) among those living without HIV, and increasing retention in care, and thus viral suppression among those living with HIV. Intervention process outcomes will assess implementation fidelity, reach, acceptability, and provider training effects. HPTN 096 is a hybrid implementation-efficacy trial that uses a single-arm interrupted time series (ITS) design to test whether a status-neutral integrated strategy improves access to and uptake of HIV prevention and treatment services for HHI MSM. The four components of the ITS are: Health access coalitions, Social media, Peer support, and Promoting Human Autonomy Supportive Environments (PHASE). ITS measures a change in slope for the primary outcomes pre- and post-intervention using four one-year lookbacks of EMR data. The integrated strategy will be delivered in three communities (Dallas, TX; Montgomery, AL; Ft Lauderdale/ Miami, FL) in the American South. Additionally, a subset of HHI MSM at PHASE healthcare facility (HCF) sites, as well as PHASE HCF staff, community coalition members, peer supporters, and both HHI MSM and other individuals who engage with the intervention’s social media content will be assessed for secondary outcomes and primary intervention process outcomes. By integrating multiple intervention strategies at the community and healthcare facility levels, HPTN 096 aims to generate evidence for scalable approaches that reduce HIV incidence in high-burden populations in the American South. The use of electric health records from participating health care clinics to assess the HPTN 096 study outcomes is an innovation for the HPTN.